Here is a more detailed description from the CMS website. It is official on the 15 mar 21 and Biden may block it ( Trump initiative ). Basically it removes the lag time between FDA final approval and then the next leg of medicare coverage process, they want the two to run in parallel to give quicker access.OnOctober 3, 2019, President Trump issued the Executive Orderon Protecting and Improving Medicare for Our Nation’s Seniors (EO 13890). Based on the EO 13890 and CMS’ continued focus on bringing new and innovative technologies to beneficiaries sooner, we are finalizing a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (MCIT), for FDA-designated breakthrough medical devices. The MCIT rule will provide national Medicare coverage as early as the same day as Food and Drug Administration (FDA) market authorization for breakthrough devices and coverage would last for 4 years. This new coverage pathway will offer beneficiaries nation-wide predictable access to new, breakthrough devices to help improve their health outcomes.
The EO 13890 alsocalled upon CMS to clarify coverage standards and consider market-basedpolicies. In this final rule, we are codifying a definition of “reasonable andnecessary” for items and services that may be covered under Part A and Part Bof the Medicare program. This definition will apply to all Medicare items andservices, not just those covered through the MCIT pathway.
Summary
The EO 13890focused, in part, on CMS streamlining coverage, coding, and payment forinnovative technology, including breakthrough medical devices. This finalrule delivers on President Trump’s order by creating an unfettered path tocoverage beginning as soon as the same day as FDA market authorization forbreakthrough devices. Manufacturers will be able to opt-in to MCIT andchoose a start date for coverage anytime within two years from the date of FDAmarket authorization. The breakthrough device designation is only givento devices that meet specific criteria from the 21st Century Cures Act. A breakthrough device mustprovide for more effective treatment or diagnosis of a life-threatening orirreversibly debilitating human disease or condition and must also meet atleast one part of a second criterion, such as by being a “breakthroughtechnology” or offering a treatment option when no other cleared or approvedalternatives exist. For beneficiaries impacted by these diseases, MCITwill provide assurance that they will have access to the latest breakthroughmedical devices to treat their condition, provided the devices have a Medicarebenefit category.
We believe fouryears of Medicare coverage will encourage manufacturers to voluntarily developevidence to show these treatments improve the health of Medicare patients. This time period for coverage will allow clinical studies with Medicare patients to be completed while providing broad immediate access and fostering innovation. When MCIT coverage sunsets, manufacturers will have all current coverage options available such as a National Coverage Determination (NCD), one or more Local Coverage Determinations (LCD), and claim by claim decisions.
Codifying adefinition of “reasonable and necessary” will bring clarity and consistency tothe existing coverage determination processes for items and services under PartA and Part B. This codification of “reasonable and necessary” is similar to thedefinition currently published in Chapter 13 of the Medicare Program IntegrityManual.
We listened tostakeholders who commented on the proposed rule, so in the final rule CMS willgather more information about utilizing commercial insurer coverage policiesand then utilize them under specific circumstances. Under the definition,generally, items and services will have to be safe and effective, notexperimental or investigational, and appropriate for Medicare beneficiaries,but if there is insufficient evidence regarding appropriateness for National orLocal Coverage Determinations (NCDs or LCDs), we can look to commercial insurerpolicies to see how they have addressed coverage.
Background
We are aware thatthere are promising technologies being designated by the FDA for expediteddevelopment and priority review through the FDA Breakthrough DevicesProgram. However, with the current Medicare coverage options, we have hadchallenges keeping national Medicare coverage on pace with these innovationsbecause of the availability of clinical evidence required to approve technologiesthrough the NCD process. To respond to this challenge, and following the EO13890, CMS is finalizing MCIT to create a more efficient coverage pathway forbreakthrough devices.
MCIT Pathway
Generally, the MCITpathway will create national Medicare coverage for breakthrough devices, theservices necessary to implant and maintain the devices, and any reasonable andnecessary treatments due to complications from the devices.
The coverage wouldlast for four years from as early as the date of FDA market authorization. (This can arise after review of a premarket notification (510(k)), De Novorequest, or premarket approval application for the device.) Based onpublic comments on the proposed, in the final rule we created the flexibilityfor manufactures to choose the start date for coverage. It can be thedate of FDA market authorization or any date two years thereafter.
Breakthroughdevices market authorized within 2 years prior to the date the final MCIT rulebecame effective will be eligible for coverage. That coverage will notexceed four years from the date of market authorization. Claims will notbe retroactively payable prior to the effective date of the rule.
Device Eligibility
The MCIT pathwaywill only be available for FDA-designated breakthrough devices (which includessome diagnostic tests) that have subsequently been market authorized. Device manufacturers must apply to the FDA for breakthrough status, and thenFDA reviews the request to determine whether the device meets the breakthroughcriteria. Not all devices receive the breakthrough designation.
Breakthroughdevices must fit within a statutory Medicare benefit category to becovered. There are breakthrough devices that do not have a Medicarebenefit category (e.g., some wearable health devices that are directlypurchased by consumers), so not all breakthrough devices can be covered byMedicare due to this statutory requirement. In addition, if CMS has issued anNCD on a particular breakthrough device, that breakthrough device is not eligiblefor MCIT.
When the FDA marketauthorizes devices, they authorize the device for specific use(s). ForMCIT, the breakthrough device must be used for the FDA approved or cleared indication(s) foruse. (This is commonly referred to as the FDA “label” or “indication”.) Uses of breakthrough device for other indications (i.e., uses not described inthe approved or cleared indication(s) for use – the “label”) are not coverablethrough MCIT.
MCIT Operations - What doDevice Manufacturers need to do?
If interested inthe MCIT pathway, manufacturers simply need to notify CMS of their interest inMCIT for their breakthrough device via an email box and specify the desiredstart date for coverage. CMS will coordinate with FDA and themanufacturer to ensure a smooth start to coverage once the breakthrough deviceis FDA market authorized. Manufacturers must still obtain the appropriatecode(s) for the device.
Breakthrough DevicesCovered through MCIT would be posted on CMS Website
CMS will post alist of breakthrough devices covered through MCIT and the duration of thecoverage on the CMS website. This will provide clarity to patients,providers, and claims processors regarding coverage.
Conclusion of MCITCoverage after 4 Years
When MCIT coveragesunsets, manufacturers would have all the current Medicare coverage pathwaysavailable (i.e., NCD, LCD, claim by claim decisions). We strongly encouragemanufacturers to communicate with CMS while utilizing MCIT. (This iscurrently a customary practice among manufacturers interested in nationalcoverage.) At some point prior to the last year of MCIT, manufacturersinterested in national coverage through an NCD or local coverage through one ormore LCDs can submit a request for coverage which would likely allow for sufficienttime for long term coverage to be finalized prior to the sunset of MCIT.
While this finalrule does not require clinical evidence development by the manufacturer, webelieve MCIT will encourage manufacturers to voluntarily develop clinicalstudies with Medicare patients to further demonstrate the long-term value ofdevices in the Medicare population and to continue national coverage after fouryears.
Definition of “Reasonableand Necessary”
The definition of“reasonable and necessary” will be codified in regulation. Thisdefinition applies more broadly than MCIT, and will be used for NCDs and othercoverage decisions. The definition has three main elements: an item orservice must be (1) safe and effective, (2) not experimental orinvestigational, and (3) appropriate for the Medicare patients.
For national and local coverage determinations, that haveinsufficient evidence to meet the appropriateness criteria, CMS will considercoverage to the extent the items or services are covered by a majority ofcommercial insurers. As part of CMS’ consideration, CMS will include inthe national or local coverage determination its reasoning for its decision ifcoverage is different than the majority of commercial insurers.
Not later than 12 months after the final rule is effective, CMSwill issue draft subregulatory guidance on the methodology of which commercialinsurers are relevant based on the measurement of majority of covered lives.
Changesfrom Proposed to Final
Based on public comment, the final rule included a more flexiblestart date for MCIT coverage. Manufacturers can choose the date MCITcoverage begins to better align with market availability. (This does notpreclude local claim-by-claim coverage before the set date.) If the FDAremoves approval of a breakthrough device, coverage through MCIT willend. Also, as stakeholders requested, CMS will gather more informationabout utilizing commercial insurer coverage policies and utilize them underspecific circumstances.
